Overview

This trial is active, not recruiting.

Condition advanced refractory left ventricular heart failure
Treatments heartmate 3 lvas, heartmate ii lvas
Sponsor Thoratec Corporation
Collaborator St. Jude Medical
Start date September 2014
End date August 2018
Trial size 1028 participants
Trial identifier NCT02224755, TC03062014

Summary

The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
heartmate 3 lvas
Implantation of HeartMate 3 LVAD to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure
(Active Comparator)
Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
heartmate ii lvas
Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure

Primary Outcomes

Measure
Short Term Survival
time frame: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.
Long Term Survival
time frame: The first 366 Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.

Secondary Outcomes

Measure
EuroQoL 5D-5L (EQ-5D-5L)
time frame: Baseline and Months 1, 3, 6, 12, 18 and 24
Kansas City Cardiomyopathy Questionnaire (KCCQ)
time frame: Baseline and Months 3, 6, 12, 18 and 24
Six Minute Walk Test (6MWT)
time frame: Baseline and Months 1, 3, 6, 12, 18 and 24
NYHA
time frame: Baseline, Discharge, and Months 1, 3, 6, 12, 18 and 24
Reoperations
time frame: As they occur up to 24 months or to outcome, whichever occurs first
Rehospitalizations
time frame: As they occur up to 24 months or to outcome, whichever occurs first
Device Malfunctions
time frame: As they occur up to 24 months or to outcome, whichever occurs first
Bleeding
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Cardiac Arrhythmias
time frame: As they occur up to 24 months or to outcome, whichever occurs first
Pericardial Fluid Collection
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Device Thrombosis
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Hemolysis
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Hepatic Dysfunction
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Hypertension
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Major Infection
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Myocardial Infarction
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Neurologic Dysfunction
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Psychiatric Episode
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Renal Dysfunction
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Respiratory Failure
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Right Heart Failure
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Arterial Non-CNS Thromboembolism
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Venous Thromboembolism Event
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Wound Dehiscence
time frame: As it occurs up to 24 months or to outcome, whichever occurs first
Other Adverse Event
time frame: As it occurs up to 24 months or to outcome, whichever occurs first

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

Inclusion Criteria: 1. Subject or legal representative has signed Informed Consent Form (ICF) 2. Age ≥ 18 years 3. BSA ≥ 1.2 m2 4. NYHA Class III with dyspnea upon mild physical activity, or NYHA Class IV 5. LVEF ≤ 25% 6. a) Inotrope dependent OR b) CI < 2.2 L/min/m2, while not on inotropes and subjects must also meet one of the following: - On Optimal Medical Management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond - Advanced Heart Failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days 7. Females of child bearing age must agree to use adequate contraception Exclusion Criteria: 1. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy 2. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator 3. Existence of ongoing mechanical circulatory support (MCS) other than IABP 4. Positive pregnancy test if of childbearing potential 5. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant 6. History of any organ transplant 7. Platelet count < 100,000 x 103/L (< 100,000/ml) 8. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management 9. History of confirmed, untreated AAA > 5 cm in diameter within 6 months of enrollment 10. Presence of an active, uncontrolled infection 11. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status 12. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: 1. An INR ≥ 2.0 not due to anticoagulation therapy 2. Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis 3. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted 4. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention 5. History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis 6. Serum creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy 7. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration 13. Patient has moderate to severe aortic insufficiency without plans for correction during pump implant 14. Pre albumin < 150 mg/L (15mg/dL) or Albumin < 30g/L (3 g/dL) (if only one available) ; pre albumin < 150 mg/L (15mg/dL) and Albumin < 30g/L (3 g/dL) (if both available) 15. Planned Bi-VAD support prior to enrollment 16. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia 17. Participation in any other clinical investigation that is likely to confound study results or affect the study 18. Any condition other than HF that could limit survival to less than 24 months

Additional Information

Official title Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol
Description The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory left ventricular heart failure; either for short term support, such as a bridge to cardiac transplantation (BTT) or myocardial recovery, or as long term support, such as destination therapy (DT). The HM3 is intended for use inside or outside the hospital.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.